Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms

Pelvic Organ Prolapse Clinical Trial

Official title:

Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms in the Treatment of Apical Compartment Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04508062
• Other study ID #: B.30.2.ATA.0.01.00/6
• Status: Completed
• Phase: N/A
• Start date: August 6, 2020
• Est. completion date: March 6, 2022

Study information

• Verified date: April 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.

Description:

In this study, the investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 6, 2022
• Est. primary completion date: March 6, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients with stage II-IV apical compartment defect according to the POP-Q classification

Exclusion Criteria:

• having severe chronic disease that makes the operation dangerous

• patients under 25 and patients over 75 years old

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• pectopexy operation
Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.
• uterosacral ligaments plication operation.
At least 2/3 of the sacrouterine ligaments will be shortened with helical sutures, starting from the cervix and so douglas will be partially obliterated.

Locations

Country	Name	City	State
Turkey	Gamze Nur Cimilli Senocak	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	questionnaire of lower urinary tract symptoms	the questionaire examines these titles by scoring from one to ten points: sudden feeling of ürination; sudden feeling of urination with incontinence; Frequent urination; Difficulty of starting the urination; Abnormal discharge of urine; nocturia; dyspareunia; Stress urinary incontinence; dysuria; constipation	changes in symptoms for each title at the preoperative day 1 and postoperative day 3 period
Primary	evaluation of sexual function with Women's Sexual Function Index	Women's Sexual Function Index is a questionnaire about sexual functions of the women. the index definex sexual functions with some questions and scorings.	changes at the preoperative day 1 and postoperative day 40 period
Primary	Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification	Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification	changes in the stage of apical compartment defect at the preoperative day 1 and postoperative day 3 period according to POP-Q clasification
Secondary	evaluation of sexual function with Women's Sexual Function Index	Women's Sexual Function Index is a questionnaire about sexual functions of the women. the index definex sexual functions with some questions and scorings.	changes at 3,6 and 12. month after surgery
Secondary	Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification	Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification	changes at 3,6 and 12. month after surgery
Secondary	questionnaire of lower urinary tract symptoms	the questionaire examines these titles by scoring from one to ten points: sudden feeling of ürination; sudden feeling of urination with incontinence; Frequent urination; Difficulty of starting the urination; Abnormal discharge of urine; nocturia; dyspareunia; Stress urinary incontinence; dysuria; constipation	changes in symptoms for each title at 3,6 and 12. month after surgery